Clinical Trial

Aromatherapy Formulas for Sundowning and Sleep Quality in Patients With Dementia.

Study acronym: AROMA-SUN
Active, Not Recruiting
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Summary
Dementia is common in aging societies and is often accompanied by sundowning syndrome and sleep problems. These symptoms can be very distressing for patients and place a heavy burden on family members and professional caregivers. Aromatherapy using essential oils, especially lavender, has shown promise in reducing behavioral symptoms in people with dementia, but evidence on compound essential oil formulas and their effects on both sundowning and sleep quality remains limited. This study will compare two different compound essential oil formulas for people with dementia living in long-term care facilities in southern Taiwan. Each participant will receive both formulas at different times in a repeated crossover design. In Phase 1, participants will receive a stimulating formula in the morning (rosemary and lemon) and a relaxing formula in the afternoon (lavender and sweet orange). In Phase 2, they will receive a calming blend that includes sweet orange, spike lavender, true lavender, vetiver, bergamot, and Roman chamomile. Aromatherapy will be administered by diffusion twice a day, five days per week, for two weeks in each phase. The main outcomes are changes in agitation and sleep quality, measured using the Chinese versions of the Cohen-Mansfield Agitation Inventory and the Pittsburgh Sleep Quality Index. The findings are expected to provide preliminary evidence on whether compound essential oil formulas can be a simple, non-drug approach to help manage sundowning syndrome and improve sleep in people with dementia.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-04.
Status change: Recruiting → Active, Not Recruiting 2026-01-06
Trial Details
NCT Number NCT07288736
Lead Sponsor National Cheng-Kung University Hospital
Conditions Dementia, Sundowning
Enrollment 35 participants
Start Date 2025-09-15
Primary Completion 2026-01-02 (estimated)
Study Completion 2026-01-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-08